Digital PCR for Quantifying Periodontal Pathobionts (dPCR)

Digital PCR for Quantifying Periodontal Pathobionts: A Comparative Study With qPCR

Comparison of quantitative polymerase chain reaction (qPCR) and digital polimerase chain reaction (dPCR) quantification of subgingival plaque samples.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Diagnostic test: digital PCR

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study comprised of two subject groups. The first group consisted of 20 subjects with periodontitis, who had at least one probing site in each jaw quadrant with pocket depth (PPD) measuring > 4 mm and positive bleeding on probing (BOP). Periodontitis stage and grade were determined following the 2018 classification system.

The second group consisted of 20 volunteers without periodontal pathologies (healthy group), i.e. plaque index < 10% at baseline visit, absence of periodontal pockets measuring > 4 mm and no prior periodontal treatment.

Description

For inclusion, each subject had to be systemically healthy and aged 20 to 80 years. Subjects were excluded if they: had less than 5 teeth in each jaw quadrant, regularly used a mouthwash as part of their oral hygiene routine, had received antibiotics during the last 6 months or during the study period, were pregnant or lactating, had a known systemic illness (i.e. HIV/AIDS, diabetes mellitus, cancer, diseases of bone metabolism, diseases affecting wound healing) or were treated with immunosuppressants, chemotherapy, radiation, calcium antagonists, antiepileptics and non-steroidal anti-inflammatory drugs.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Periodontitis patients	Diagnostic test: digital PCR; digital PCR quantification of subgingival plaque samples
Individuals with healthy periodontium	Diagnostic test: digital PCR; digital PCR quantification of subgingival plaque samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
concentration of targeted bacterial species, expressed as genome equivalents per mL (Geq/mL), normalized for ribosomal gene copy number per cell	Baseline

Collaborators and Investigators

• Sponsor: University of Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Actual): October 20, 2024
• Study Completion (Actual): November 2, 2024

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases
• Other Study ID Numbers: UKCdPCR1; J7-4639 (Other Grant/Funding Number: ARIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No